Hypersensitivity, Pediatrics
Conditions
Keywords
child life services, skin prick test, pain, anxiety, pediatric nursing
Brief summary
The goal of this clinical trial is to determine whether child life services can enhance the experiences of children and caregivers during skin prick testing. The main questions it aims to answer are: 1. Can child life services alleviate children's pain and enhance procedural compliance? 2. Can child life services reduce caregivers' anxiety and improve their satisfaction? Researchers will compare children who receive child life services with those who receive standard care to determine whether the intervention can optimize procedural experience and overall satisfaction. Participants will receive either child life services or standard care during the skin prick test.
Detailed description
The skin prick test (SPT) is an essential diagnostic tool for IgE-mediated allergic diseases and a foundation for allergen immunotherapy. However, the multiple needle pricks involved often cause pain and anxiety in children, while caregivers frequently experience heightened stress. Child life services aim to help children feel safe and relaxed in medical settings, thereby reducing distress and improving cooperation. This study applied child life services during pediatric SPT to alleviate children's pain, boost procedural compliance, reduce procedural duration and interruptions, and enhance caregiver satisfaction while alleviating their anxiety.
Interventions
BEHAVIORALStandard Care (in control arm)
Nurses introduce the environment, personnel, and procedure, review the child's medical and allergy history, and confirm informed consent. The SPT is then performed according to clinical standards. After the procedure, children remain under observation, during which nurses monitor for any discomfort and provide guidance to avoid scratching the test site. Finally, nurses measure and interpret the results and provide basic health education to the child and caregivers.
BEHAVIORALchild life services
Children in the intervention group receive standard care plus support from a Child Life Specialist (CLS) throughout the SPT procedure. The CLS provides age-appropriate preparation, distraction, and emotional support to both children and caregivers before, during, and after the procedure. The CLS also monitors the child's responses, helps manage any anxiety or resistance, supports caregivers emotionally, and explains test results and post-procedure care in an understandable manner.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Participants are assigned to one of two groups (intervention or control) based on visit time, with each group receiving a single intervention throughout the study.
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Meet the indications for skin prick test (SPT) * Aged 1-18 years * Voluntarily agree to participate in the study and provide informed consent
Exclusion criteria
* Meet the contraindications for SPT * Presence of psychiatric disorders or cognitive impairment * Severe dysfunction of vital organs such as the heart, brain, or kidneys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Face, Legs, Activity, Cry, Consolability (FLACC) scale score | Periprocedural | Use the FLACC scale to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain). |
| the Wong-Baker FACES score | Periprocedural | Use the Wong-Baker FACES scale to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain). |
| the Visual Analogue Scale (VAS) score | Periprocedural | Use the Visual Analogue Scale (VAS) to assess pain, higher scores indicate greater pain (0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain). |
| Child procedural compliance | Periprocedural | During the skin-prick test, compliance was rated as: Full: complete cooperation with the nurse; Partial: test completed despite crying or resistance; None: test impossible owing to non-copliance Overall compliance rate = (full + partial) / total × 100%. A higher overall compliance rate indicates better overall compliance with the skin-prick test procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration | Periprocedural | — |
| Number of interruptions | Periprocedural | — |
| Caregiver anxiety | within 10 minutes after skin-prick test | Caregiver anxiety was assessed with the 10-item short-form State-Trait Anxiety Inventory (five state and five trait items); each item is scored 1-4, with higher total scores indicating greater anxiety (Cronbach's α = 0.918). |
| Caregiver satisfaction | within 10 minutes after skin-prick test | satisfaction was rated by caregivers on a 5-point scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied, 1 = very dissatisfied. |
Countries
China
Contacts
CONTACTXinyi RONG
Outcome results
None listed